FDA.reportPublic FDA data

SUAVECITO 5% Minoxidil Solution

Product NDC
74866-414
11-digit product format
748660414
Labeler code
74866
Product ID
74866-414_00bf0083-4ef5-76ef-e063-6294a90a9907
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
SUAVECITO, INC.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2023-07-31
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUAVECITO 5% Minoxidil Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74866-414-01SUAVECITO 5% Minoxidil Solution60 mL in 1 BOTTLELIQUID601
74866-414-01SUAVECITO 5% Minoxidil Solution1 in 1 BOXLIQUID11
74866-414-03SUAVECITO 5% Minoxidil Solution60 mL in 1 BOTTLELIQUID601
74866-414-03SUAVECITO 5% Minoxidil Solution3 in 1 BOXLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74866-414SUAVECITO 5% MINOXIDIL SOLUTION (MINOXIDIL) LIQUID [SUAVECITO, INC.]1Current NDC, 4 package rows20230731_a6d3c488-f943-4edf-9d6b-21a3dee92d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNa6d3c488-f943-4edf-9d6b-21a3dee92d781
311724minoxidil 50 MG/ML Topical SolutionSCDa6d3c488-f943-4edf-9d6b-21a3dee92d781
311724minoxidil 3 GM per 60 ML Topical SolutionSYa6d3c488-f943-4edf-9d6b-21a3dee92d781
311724minoxidil 5 % Topical SolutionSYa6d3c488-f943-4edf-9d6b-21a3dee92d781
311724minoxidil 5 GM per 100 ML Topical SolutionSYa6d3c488-f943-4edf-9d6b-21a3dee92d781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74866-414-01748660414011 BOTTLE in 1 BOX (74866-414-01) / 60 mL in 1 BOTTLE1 bottle2023-07-31NoNoHistorical
74866-414-03748660414033 BOTTLE in 1 BOX (74866-414-03) / 60 mL in 1 BOTTLE3 bottle2023-07-31NoNoHistorical